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PROCEEDINGS - August 10, 2020
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`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________________
` )
`MYLAN PHARMACEUTICALS, )
` )
`INC., )
` )
` Petitioner, )
` ) U.S. Patent No.
` vs. ) 7,326,708
` )
`MERCK SHARP & DOHME )
` )
`CORPORATION, )
` )
` Patent Owner. )
` )
`__________________________)
`
` REPORT OF PROCEEDINGS via teleconference
`
`of the above-entitled cause before the Honorable
`
`Timothy G. Majors and Sheridan K. Snedden, Judges
`
`of said Panel, on the 10th day of August, 2020, at
`
`2:32 p.m.
`
`Reported by: Cappy Hallock, RPR, CRR
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1018 p. 001
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`

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`PROCEEDINGS - August 10, 2020
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`Page 2
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` A P P E A R A N C E S
` (All appearances telephonically)
`
` On behalf of Petitioner Mylan Pharmaceuticals
`
` Inc.:
`
` JITENDRA MALIK, PHD
`
` Katten Muchin Rosenman, LLP
`
` 550 South Tryon Street, Suite 2900
`
` Charlotte, North Carolina 28202
`
` 704-444-2000
`
` jitty.malik@katten.com
`
` On behalf of Petitioner Dr. Reddy's
`
` Laboratories:
`
` RUSSELL W. FAEGENBURG, ESQUIRE
`
` Lerner David Littenberg Krumholz
`
` Mentlik LP
`
` 20 Commerce Drive
`
` Cranford, New Jersey 07016
`
` 908-654-5000
`
` rfaegenburg@lernerdavid.com
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1018 p. 002
`
`

`

`PROCEEDINGS - August 10, 2020
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`Page 3
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`APPEARANCES: (Continued)
`
` On behalf of Petitioners Teva Pharmaceuticals
`
` and Watson Laboratories:
`
` EMILY L. RAPALINO, ESQUIRE
`
` SARAH J. FISCHER, ESQUIRE
`
` Goodwin Procter LLP
`
` 100 Northern Avenue
`
` Boston, Massachusetts 02210
`
` 617-570-1000 (P) 617-523-1231 (F)
`
` erapalino@goodwinlaw.com
`
` sfischer@goodwinlaw.com
`
` On behalf of Petitioner Sun Pharmaceuticals:
`
` JOVIAL WONG, ESQUIRE
`
` CLAIRE A. FUNDAKOWSKI, ESQUIRE
`
` Winston & Strawn LLP
`
` 1901 L Street NW
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` Washington, D.C. 20036
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` 202-282-5000
`
` jwong@winston.com
`
` cfundakowski@winston.com
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1018 p. 003
`
`

`

`PROCEEDINGS - August 10, 2020
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`Page 4
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`APPEARANCES: (Continued)
`
` On behalf of the Patent Owner Merck
`
` Sharp & Dohme Corporation:
`
` STANLEY E. FISHER, ESQUIRE
`
` BRUCE R. GENDERSON, ESQUIRE
`
` ELISE M. BAUMGARTEN, ESQUIRE
`
` Williams & Connolly LLP
`
` 725 12th Street, NW
`
` Washington, D.C. 20005-5901
`
` 202-434-5000
`
` sfisher@wc.com, bgenderson@wc.com,
`
` ebaumgarten@wc.com
`
`Court Reporter:
`
`Cappy Hallock, RPR, CRR
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`GregoryEdwards, LLC | Worldwide Court Reporting
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`Mylan (IPR2020-00040) Ex. 1018 p. 004
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`

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`PROCEEDINGS - August 10, 2020
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` P R O C E E D I N G S
`
` - - - - - -
`
` JUDGE MAJORS: We are here today for a
`
`conference call related to a number of petitions,
`
`including IPR2020-00040 and other related
`
`petitions, challenging the same patent,
`
`IPR2020-01045, -01060 and -01072.
`
` It sounded to me like we have counsel
`
`for the Petitioners in each of those cases as well
`
`as Merck's counsel on as well, so why don't we
`
`kick things off.
`
` We have looked at the request. It
`
`looks as though the parties have filed a
`
`stipulation to change, to modify some of the
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`dates, and based on the request sent via e-mail
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`it's only that portion of due date 2 that the
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`parties need Board authorization to change that is
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`at issue at the moment.
`
` So with that, Mr. Malik, I don't know
`
`if you will be speaking on the Petitioners' part,
`
`and Mr. Fisher, if you will be speaking on Merck's
`
`part, why don't we kick things off and I will open
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1018 p. 005
`
`

`

`PROCEEDINGS - August 10, 2020
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`the floor up to Patent Owner first.
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` MR. FISHER: Sure, Your Honor. I
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`think you have it spot on. I think there is a
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`stip that Mylan and Patent Owner Merck put on file
`
`on Friday to move due date 1 by one week. And you
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`are right, Your Honor, it is this call where Mylan
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`and Merck jointly I think seek leave to move the
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`portion of due date 2, which I think is due date
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`2B, to extend that by a week as well. So I think
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`that probably would be the easiest part of this
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`call.
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` MR. MALIK: Mylan agrees with Merck's
`
`petition. Basically we reached agreement on the
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`due dates that we could move by a week. That was
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`most of the issues that we were going to bring
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`today before Your Honor, and then due date 2A we
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`just need your permission to move it back one week
`
`per the scheduling order. I think that's the only
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`thing on the table as it relates to the scheduling
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`issues.
`
` JUDGE MAJORS: And that modification
`
`to the schedule is not opposed by anyone; is that
`
`GregoryEdwards, LLC | Worldwide Court Reporting
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`
`Mylan (IPR2020-00040) Ex. 1018 p. 006
`
`

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`PROCEEDINGS - August 10, 2020
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`Page 7
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`right?
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` Hello? Did I drop off?
`
` (Unidentified speaking.)
`
` SPEAKER: No, no, no. Not that we are
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`aware of.
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` MR. MALIK: I took the silence as no
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`one is aware of --
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` THE REPORTER: Gentlemen, when you
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`speak I will need you to identify yourselves.
`
` MR. MALIK: Sure. That was Jitendra
`
`Malik for Mylan. Sorry, court reporter.
`
` THE REPORTER: Thank you.
`
` JUDGE MAJORS: All right, this is
`
`Judge Majors. We will then go ahead. We will
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`authorize the change to that part of due date 2 to
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`line up with the other stipulated changes to the
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`due date, which I guess is, what, moving it to
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`November 21st then?
`
` MR. MALIK: November 13th.
`
` JUDGE MAJORS: November 15th?
`
` MR. MALIK: 13th.
`
` JUDGE MAJORS: Hold on, give me one
`
`GregoryEdwards, LLC | Worldwide Court Reporting
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`
`Mylan (IPR2020-00040) Ex. 1018 p. 007
`
`

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`PROCEEDINGS - August 10, 2020
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`Page 8
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`second.
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` Okay, you are right. I'm sorry, I had
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`written it down wrong. So from the 6th to the
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`13th.
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` MR. MALIK: Yes, Your Honor.
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` JUDGE MAJORS: All right, is there
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`anything else from the parties' perspectives that
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`we needed to raise on today's call?
`
` MR. FISHER: Your Honor, this is Stan
`
`Fisher. I think we wanted to simply update Your
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`Honors as to where things stood from our
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`perspective with respect to joinder. I'm not sure
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`that there is anything we necessarily need to
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`resolve today. We, if you recall we had a
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`discussion a few weeks back, maybe even a month
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`ago now, about the joinder process and attempting
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`to expedite it to potentially reach some
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`resolution before our Patent Owner response was
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`due.
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` Briefing has been completed on the
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`joinder motions filed by Joinder Petitioners, and
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`I believe that as of the reply brief going in,
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`
`Mylan (IPR2020-00040) Ex. 1018 p. 008
`
`

`

`PROCEEDINGS - August 10, 2020
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`Page 9
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`Merck can report that we see that there is
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`agreement amongst Merck and the Joinder
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`Petitioners on the understudy role that the
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`Joinder Petitioners would play. We had a brief
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`conferral call after that reply brief went in and
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`I think we were able to confirm that in fact we
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`are in agreement on the various understudy
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`conditions which I believe are reported in the
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`various briefs and correspondence between the
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`parties.
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` I think that the one aspect that was
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`outstanding from Merck's position was what to do,
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`if anything, about the sequencing of party
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`discovery and, you know, I can report from Merck's
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`perspective my understanding is, and I will let my
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`counterparts representing Mylan and Teva can
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`certainly speak for themselves, but my
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`understanding is that Mylan is not intending to
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`rely on Dr. Len Chyll who is the declarant that
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`Teva submitted a declaration on behalf of them.
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`My understanding is that as of this morning Teva
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`has withdrawn the declaration of Dr. Chyll in view
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`GregoryEdwards, LLC | Worldwide Court Reporting
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`
`Mylan (IPR2020-00040) Ex. 1018 p. 009
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`

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`PROCEEDINGS - August 10, 2020
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`Page 10
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`of the fact that Mylan's declarant, Dr. Torgotti,
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`was deposed last week.
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` You know, at this point in time we
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`don't oppose joinder on the basis of the fact that
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`if we were to seek discovery it wouldn't happen
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`until after joinder is granted. We would like to
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`make clear that we certainly would reserve the
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`right to seek discovery if joinder is ordered by
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`the Board. I think the Board has referenced in
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`the past that perhaps these issues of making use
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`of any discovery, if discovery is made available,
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`could be dealt with in a surreply or a
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`supplemental brief of some sort.
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` So I wanted to update the Board as to
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`where Merck stood at this point in time as it
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`doesn't look like any of this is going to happen
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`before our Patent Owner response would be due,
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`would be due in, I guess, a little under two weeks
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`now. So I will stop there.
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` JUDGE MAJORS: Thank you for that,
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`Mr. Fisher. I was going to ask you, or ask the
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`parties about the status on the joinder issues. I
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`GregoryEdwards, LLC | Worldwide Court Reporting
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`
`Mylan (IPR2020-00040) Ex. 1018 p. 010
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`

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`PROCEEDINGS - August 10, 2020
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`Page 11
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`have looked at the papers, and as we talked about
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`at length last time -- we don't need to go through
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`all the details again, but it's good to hear I
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`guess there is agreement in principal on the
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`understudy role -- and if I hear you correctly it
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`seems that Merck is saying well, you don't oppose
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`joinder but you are reserving your right vis-à-vis
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`the discovery that is mentioned in the various
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`papers -- and I will swing back to you in a second
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`and you can tell me if that's wrong -- in which
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`case I think then the only outstanding issue for
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`the Board in getting to the joinder motion is what
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`Patent Owner is going to do relative to the
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`preliminary response in those other three cases.
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` I know when we spoke last time I asked
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`what Patent Owner's intention was and I think it
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`was something to the effect that well, we are not
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`thinking about filing that but it was -- I don't
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`think it was set in stone at that time.
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` But via statute, Section 315, we have
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`to either wait for the Patent Owner's preliminary
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`response to come in or for the time to pass or I
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`
`Mylan (IPR2020-00040) Ex. 1018 p. 011
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`

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`PROCEEDINGS - August 10, 2020
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`Page 12
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`guess alternatively get some paper saying for
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`Patent Owner's part we are not going to file -- we
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`are reserving our right but we are not going to
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`file a Patent Owner preliminary response so we can
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`move on to address the joinder issues.
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` All that being said, I will turn it
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`back to you, Mr. Fisher, first, to see if Patent
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`Owner is not going to file a preliminary response
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`and we can get on with the joinder issue then I
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`think we will need some affirmative filing from
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`Patent Owner to make that a record.
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` MR. FISHER: This is Stan Fisher.
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` Fair enough, Your Honor. I don't
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`believe we intend to file any preliminary response
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`but certainly can put a paper on file to that
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`effect after, you know, finally conferring with
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`our client on the point. But, yes, I believe
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`that's where we are at right now.
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` JUDGE MAJORS: Okay. As soon as we
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`get that paper in we can move on to addressing the
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`joinder issue I think relatively quickly. But
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`unless we get something confirming that no
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`
`Mylan (IPR2020-00040) Ex. 1018 p. 012
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`

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`PROCEEDINGS - August 10, 2020
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`Page 13
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`preliminary response is coming in we are in a
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`little bit of a limbo right now.
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` MR. FISHER: Okay. This is Stan
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`Fisher. To be quite honest, I didn't realize that
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`was the one thing holding things up and had I
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`realized that we would have put something in much
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`sooner. Absolutely we will get something in as
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`soon as I can.
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` JUDGE MAJORS: Okay.
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` And not to monopolize the call,
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`anything from you, Mr. Malik, or any of the other
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`Petitioners that need to speak up?
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` MR. MALIK: This is Mr. Malik.
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` Nothing specific, Your Honor.
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`Obviously we will reserve our rights regarding any
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`discovery they may raise in connection with any of
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`the other Joint Petitioners and Dr. Chyll. As
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`Mr. Fisher notes, our expert is Dr. Torgotti.
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`That's the one, the expert that provided the
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`declaration with our petition. He was deposed
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`last week. So basically we will cross the
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`remaining bridges when we get to it if and when
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`
`Mylan (IPR2020-00040) Ex. 1018 p. 013
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`

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`PROCEEDINGS - August 10, 2020
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`Page 14
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`Merck decides to file any discovery motion and so
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`on and so forth.
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` JUDGE MAJORS: Okay.
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` Anything for the other Petitioners? I
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`know you are taking an understudy role but is
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`there anything you need to raise at the moment?
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` MS. RAPALINO: This is Emily Rapalino
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`for the Teva and Watson Petitioners. There is
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`nothing from us. Mr. Fisher covered the update of
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`where we are, and I think in light of the fact
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`that there are no more disputes with respect to
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`the understudy role and the parties seem to be in
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`agreement that we can address the discovery issues
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`at a later date after the joinder issue is
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`resolved I don't think there is anything further
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`from us.
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` JUDGE MAJORS: Well, thank you for
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`that.
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` So then, Mr. Fisher, we will just be
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`on the lookout, then. Obviously check with the
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`client and make sure that the Patent Owner is in
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`fact not going to file anything, but you can file
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`
`Mylan (IPR2020-00040) Ex. 1018 p. 014
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`

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`PROCEEDINGS - August 10, 2020
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`Page 15
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`it however you want. You can call it a
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`preliminary response and just refer to what
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`happened earlier. You can, you know, reserve your
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`rights, and of course you disagree with the
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`challenge and with the Board, the Board paper for
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`institution, but you will waive this particular
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`filing and address it in the Patent Owner
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`response.
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` Just so we have something so we know
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`and can move on so we can get over that 315
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`hurdle.
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` MR. FISHER: Absolutely, Your Honor.
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`This is Stan Fisher. We will do exactly that.
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` JUDGE MAJORS: Okay.
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` All right, well, thank you everyone.
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`Unless there is anything further why don't we
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`adjourn. Every one enjoy the rest of the day.
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` ALL: Thank you, Your Honor.
`
` (Off the record at 2:45 p.m.)
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1018 p. 015
`
`

`

`PROCEEDINGS - August 10, 2020
`
`Page 16
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`UNITED STATES OF AMERICA )
`
`STATE OF MARYLAND )
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` I, CAPPY HALLOCK, the reporter before
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`whom the foregoing proceedings were taken, do
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`hereby certify that the foregoing transcript is a
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`true record of the proceedings.
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` I further certify that I am neither
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`counsel for, related to, nor employed by any of
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`the parties to the action in which these
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`proceedings were taken; and further that I am not
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`a relative or employee of any attorney or counsel
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`employed by the parties hereto, or financially or
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`otherwise interested in the outcome of this
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`action.
`
` _______________________
`
` Cappy Hallock, RPR, CRR
`
`My Commission expires January 19, 2021
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Mylan (IPR2020-00040) Ex. 1018 p. 016
`
`

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